Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a rapid, immunochromatographic assay for the qualitative detection of intact hHb (human hemoglobin) in fecal specimens. It is a convenient and hygienic method for detecting human fecal occult blood, which may be in dicative of gastrointestinal disease associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.

Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is an immunological test for both professional and over the counter use.

Device Description

Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a qualitative, sandwich colloidal gold conjugate immunoassay for the determination of human hemoglobin in feces. The method employs a unique combination of monoclonal antibodies to selectively identify hemoglobin in test sample with a high degree of sensitivity. In less than 5 minutes, elevated levels of human hemoglobin as low as 50 ng/ml can be detected, and positive results for high levels of hemoglobin can be seen in the test as early as two to three minutes. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody- conjugate binds to the hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to another anti-hemoglobin antibody in the positive reaction zone and produces a pink-ross color band when hemoglobin concentration is greater than 50 ng/ml. In the absence of hemoglobin, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the positive reaction zone and negative control zone. Unbind conjugate binds to the reagents in the negative control zone, producing a pink rose color band, demonstrating that the reagents and device are functioning correctly.

A NEGATIVE specimen produces one distinct color bands in control area. A POSITIVE specimen produces two color band in the control and test area. There is no meaning attributed to color or its intensity for either line.

AI/ML Overview

Here's an analysis of the provided text regarding the Forsure One Step Fecal Occult Blood (FOB) Screen Card Test, focusing on acceptance criteria and study information:

Analysis of Acceptance Criteria and Study Data for K063693

The 510(k) summary for K063693 focuses on demonstrating substantial equivalence to a predicate device (WHPM Hemosure One Step Fecal Occult Blood (FOB) Test, K041202) through comparison of intended use and physical properties. It does not provide detailed performance characteristics from a specific study with acceptance criteria in the typical format of sensitivity, specificity, and accuracy for diagnostic devices, nor does it detail a clinical trial.

Instead, the provided text emphasizes the device's analytical performance (detection limit) and then asserts "substantial equivalence" based on similar characteristics to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission, actual "acceptance criteria" for a study in terms of clinical performance metrics (sensitivity, specificity) are not explicitly stated or provided in the document as would be found in a detailed clinical evaluation report. The document, instead, focuses on analytical performance.

Acceptance Criteria (Implied / Analytical)	Reported Device Performance
Detection of elevated human hemoglobin	Detects elevated levels of human hemoglobin as low as 50 ng/ml.
Time to result for positive samples	Positive results for high levels of hemoglobin seen as early as two to three minutes.
Time to result overall	In less than 5 minutes.
Comparison to Predicate Device's Cutoff	Cutoff is same as predicate (50 ng/ml or 50 ug/g of feces).
Performance similar to predicate device (K041202)	"Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices."

Note: The above table reflects the analytical performance claims and the basis for substantial equivalence as presented in the 510(k) summary. It does not contain clinical performance metrics (sensitivity, specificity, etc.) that would typically be derived from a clinical study with explicitly stated acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not mention or describe a specific test set sample size used for performance evaluation that would lead to clinical sensitivity or specificity data. The "substantial equivalence" claim is based on comparisons of intended use, physical properties, and analytical performance (detection limit and speed), rather than a clinical comparison study on a patient cohort.

Therefore, details such as:

Sample size: Not specified for a clinical test set.
Data provenance: Not specified.
Retrospective or prospective: Not applicable as a clinical test set is not described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The document does not describe a clinical study where experts established a ground truth for a test set. The evaluation is focused on analytical capabilities and equivalence to a predicate, not on a new clinical performance assessment requiring expert consensus on diagnoses.

4. Adjudication Method for the Test Set

Not applicable. As there is no described clinical test set requiring expert ground truth, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done according to the provided 510(k) summary. The submission focuses on device characteristics and analytical performance, not on evaluating human reader performance with or without the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself, the Forsure One Step Fecal Occult Blood (FOB) Screen Card Test, is a standalone test. It's a "visually-read single use device" that produces a result (positive/negative) without further algorithmic interpretation. The "algorithm" here is the immunochromatographic reaction itself, yielding a visual output. The performance described (detecting 50 ng/ml hemoglobin, producing a result in <5 minutes) refers to this standalone analytical function.

7. The Type of Ground Truth Used

For the analytical claims (e.g., detection limit of 50 ng/ml), the "ground truth" would be established by:

Spiking known concentrations of human hemoglobin into control fecal specimens or appropriate matrices.
Reference laboratory methods to confirm the concentration of hemoglobin.

For the substantial equivalence claim, the "ground truth" is that the predicate device (WHPM Hemosure K041202) is already legally marketed and presumed safe and effective, and the new device operates on the same principles and achieves similar analytical performance (e.g., cutoff) and intended use.

8. The Sample Size for the Training Set

Not applicable. This device is an immunochromatographic assay, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense. Development would involve R&D and optimization based on known chemical/biological principles, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question does not apply. The development of such a test relies on established biochemical principles and laboratory validation.

Summary

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K063693
MAY 11 2007

510(k) Submission For Forsure One Step Fecal Occult Blood (FOB) Screen Card Test New Bay Bioresearch Co., Ltd.

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: Designed (k) Number to be Determined

Submitter:

Tianjin New Bay Bioresearch Co., Ltd. #3 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianjin, China Telephone: 86-22-28751515 Facsimile: 86-222-875-1516

Contact Person:

Rodrigo Berlie New Product Development Director Telephone: (760) 828-0990 Facsimile: (760) 602-2999

Preparation Date:

December 08, 2006

Device Information:

Trade or Proprietary Name: Forsure One Step Fecal Occult Blood (FOB) Screen Card Test

Common/Usual Name: Lateral flow immunochromatographic assay for detection of human hemoglobin or fecal occult blood in feces

Device Classification Name: Immunoassay of human hemoglobin or fecal occult blood

Regulatory Name: Human Hemoglobin or Fecal Occult Blood (FOB) Test System

Regulation Section: 21 CFR § 866. 6550

Regulatory Class: Class II

Product Code: KHE

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Panel: Hematology (81)

Predicate Devices:

Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is substantially equivalent to WHPM Hemosure One Step Fecal Occult Blood (FOB) Test cleared by FDA (K041202) for its stated intended use.

Device Description:

Intended Use:

Comparison to Predicate Device(s):

Both devices (Forsure and WHPM) are for the qualitative determination of the Fecal Occult Blood. The specific antibodies against human hemoglobin were used in both devices. All test devices are visually -read single use device. The cutoff of each analyte is same (50 ng/ml or 50 ug/g of feces).

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Summary:

The information provided in this pre-market notification demonstrates that Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is substantially equivalent to WHPM Hemosure One Step Fecal Occult Blood (FOB) Test. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supplied in this pre-market notification provides reasonable assurance that the Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is safe and effective for its stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

New Bay Bioresearch Company, Limited C/O Aventir Biotech, LLC 3108 Avenida Olmeda Carlsbad, California 92009 ATTN: Rodrigo Berlie

MAY I 1 2007

Re: K063693

Trade/Device Name: Forsure One Step Fecal Occult Blood (FOB) Screen Card Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: December 11, 2006 Received: December 14, 2006

Dear Mr. Berlie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Rodrigo Berlie

notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker, Jr., M.D., Ph.D.

Robert L. Becker, Jr., M.D Director Division of Immunology and Hematology

Office of In Vitro Diagnostic Device Evaluation and Safety

Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

K063693.

Device name: Forsure One Step Fecal Occult Blood (FOB) Screen Card Test

Indications for Use:

Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is an immunological test for both professional and over the counter use.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use 7 (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robe R. Rote/
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K063693

CONFIDENTIAL

Regulation Number and Section

§ 864.6550 Occult blood test.

(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.